The Provisions on Supervision and Management of Children’s Cosmetics were released on September 30, 2021, further refining the supervision of children’s cosmetics. Under the premise of the above regulations and amendments, the State Drug Administration organized the CIQ to formulate special “Technical Guidelines for Children’s Cosmetics”, which was released on August 31, 2023.
How should enterprises properly prepare the technical information of children’s cosmetics? I take you to run through it.
1. Definition
Children’s cosmetics mainly refers to cosmetics for children under 12 years of age (including 12 years of age). These products have cleaning, moisturizing, toning, sunscreen, and other effects to meet the basic skin care needs of children. In the product labeling, if it is indicated that “suitable for the whole population”, “the whole family to use” and other words, or the use of trademarks, patterns, harmonies, letters, Hanyu pinyin, numbers, symbols, packaging forms, etc. imply that the product use of the population including children, then these products Should follow the relevant regulations and technical standards for children’s cosmetics.
For the use of cosmetics for “infants and young children”, its efficacy claims are limited to six aspects cleaning, moisturizing, hair care, sunscreen, soothing, and toning. In the use of cosmetics for the population of “children”, the efficacy claims are limited to cleaning, make-up removal, moisturizing, cosmetic modification, fragrance, hair care, sunscreen, repair, soothing, and toning these ranges. If the efficacy claims of children’s cosmetics exceed these ranges, then they should apply for registration as new efficacy cosmetics. This provision not only helps to protect children’s skin health but also to ensure the standardized development of the children’s cosmetics market.
2. Raw materials
For children’s cosmetics, the choice of raw materials has strict requirements. First of all, should be used in the history of cosmetics have been widely used and have a history of safe use of raw materials, but can not use new raw materials are still in the safety monitoring stage. In addition, the use of raw materials whose safety for children is not clear or which pose a certain risk should also be avoided.
In some special cases, if there are no suitable alternative raw materials available, a new technology with a specific risk of the preparation of raw materials, then in this case, the need for product safety assessment needs to be explained in the product safety assessment and the detailed evaluation of the safety of use for children.
At the same time, the “Technical Code for Cosmetic Safety” has strict requirements for the raw materials used in children’s cosmetics. All raw materials used in children’s cosmetics must comply with the relevant provisions of the Code, and cannot use those ingredients that are explicitly prohibited for use in children’s cosmetics. In addition, some raw materials that may have specific safety risks, such as formaldehyde releasers, and other countries or regions listed as prohibited substances, also need to avoid the use of raw materials.
However, “baby” cosmetics have more stringent raw material requirements. These products cannot use raw materials such as isopropanol butyl carbamate (except for bath products and shampoos), salicylic acid and its salts (except for shampoos), or silver chloride deposited on titanium dioxide. At the same time, children’s cosmetics cannot use ingredients whose main purpose is to remove spots and whiten the skin, remove acne, remove hair, deodorize, remove dandruff, prevent hair loss, dye hair, and perm hair. If raw materials that may have the above effects are used for other purposes, the necessity of their use and the safety of their use in children’s cosmetics must be evaluated.
3. Execution standards
Children’s cosmetics are products designed and used exclusively by children, so their microbiological physical and chemical indexes need to comply with strict standards and regulations. The Safety Technical Code for Cosmetics is the basic standard for guaranteeing the safety and effectiveness of cosmetics, and the microbiological indicators of children’s cosmetics, such as total colony count ≤ 500 CFU/mL (CFU/g), are also one of the regulations that must be met.
In addition to microbiological indicators, the Guiding Principles also stipulate the physical and chemical indicators of children’s cosmetics. The control range of the restricted components in the physical and chemical indicators must be set by the requirements of the “Technical Code for Cosmetic Safety” based on the amount of formula filling and in combination with the control of product quality (e.g., test results, stability of the product during the shelf life, etc.) to ensure that it is within a reasonable range. If it exceeds the reasonable range, a sufficient basis must be provided to illustrate the stability of the product process and the controllability of product quality.
In addition, the “Guiding Principles” for the first time from the regulatory level to clarify the range of pH value in the physical and chemical indicators of children’s cosmetics. In principle, children’s cosmetics should set a pH range (except for dosage forms for which pH cannot be measured). The pH range of resident cosmetics should be 4.5~7.5 (including 4.5 and 7.5); the pH range of drenching cosmetics should be 4.5~8.5 (including 4.5 and 8.5). If taking into account the physiological characteristics of specific areas of use (such as infant diaper area), product properties and stability of raw materials, and other factors, setting the pH range belongs to any of the following cases, should provide a scientific and reasonable explanation, and conduct a full safety assessment: (1) set the lower limit of the pH range of ≥ 3.5 but <4.5; (2) the upper limit of the pH range of the residual cosmetics set> 7.5 but ≤ 10.5; (3) set the upper limit of pH range for showering cosmetics >8.5 but ≤10.5.
4. Warning
Children’s cosmetics must strictly comply with the requirements of the Regulations for the Supervision and Administration of Children’s Cosmetics and other relevant regulations during the production, sale, and use of children’s cosmetics. These regulations stipulate that children’s cosmetics must be labeled with safety warnings, and should be informed of the risks and precautions that may exist in the product by using a conspicuous “Caution” or “Warning” as a guide. In addition, when restricted components are used in children’s products, the manufacturer must indicate the corresponding conditions of use and precautions on the label to ensure that children are properly instructed in the process of use and to avoid accidents caused by improper use.
In addition to the above basic requirements, the Guiding Principles have also refined and clarified the classification and coding of children’s cosmetics, claims of efficacy, conditions of use, and precautions. For example, for flammable products such as pressure-filled solvents, manufacturers must mark the appropriate warning terms on the product label and inform consumers of the possible risks of the product. Meanwhile, the Guidelines also specify the requirements for special products such as classification codes, children’s cosmetics with efficacy claims of makeup removal/beauty modification, and the use of aerosolized children’s sunscreen cosmetics, to ensure the safety and efficacy of these products.
5. Label Content
Children’s cosmetics should maintain independence and clarity to avoid confusion with food, drugs, and other products, and to prevent children from accidental ingestion and misuse. Therefore, the characteristics of children’s cosmetics such as traits, odor, appearance, and form should be different from those of adult cosmetics to avoid misuse by children. In addition, the ingredients of children’s cosmetics should not contain prohibited labeling or claims, and should not be labeled with terms such as “food grade” and “edible” or food-related patterns to prevent children from accidentally consuming them.
To facilitate consumer identification and purchase, children’s cosmetics should be in the sales package can be easily observed on the upper left side of the display surface by the provisions of the State Drug Administration “on the release of children’s cosmetic logo announcement” (No. 143 of 2021) marked with children’s cosmetics logo. This logo should be clear, easy to understand, and can remind consumers whether the product is suitable for children.
In addition, children’s cosmetics labeling safety warnings should be marked with “attention” or “warning” as a guide to remind consumers that the product needs to be used properly by the instructions to avoid accidents. At the same time, sunscreen children’s cosmetics shall not encourage consumers to be exposed to the sun or guarantee the effect of sunscreen absolute claims, to avoid consumer misunderstanding and misuse.
To summarize, children’s cosmetics should maintain independence and clarity to avoid confusion with food, drugs, and other products, and to prevent children from misuse and misuse. At the same time, the labels should be marked with clear, easy-to-understand signs and safety warnings, and should not contain absolutized claims.
6. Inspection reports
Product inspection report is an important document issued by the cosmetic registration and filing inspection agency, its content should be consistent with the “Technical Code for Cosmetic Safety”, “Cosmetics Registration and Filing Inspection Code of Practice” and other relevant laws and regulations and technical standards. These provisions and standards are to ensure the safety and effectiveness of cosmetics and to protect the health and rights of consumers.
According to the “Regulations on the Administration of Cosmetic Registration and Filing Information”, products claiming to be for use by infants and children cannot be exempted from the requirements of toxicology test reports. This is because children’s cosmetics are intended for use by younger children, whose skin structures are not yet fully developed, and whose absorption of and reaction to ingredients and chemical substances in cosmetics will be different, so more stringent toxicology tests are required to safeguard the safety and efficacy of children’s use.
In the Guiding Principles, the results of acute eye irritation/corrosion tests for children’s cosmetics are required to be non-irritating or slightly irritating, and tear-free formulations can be claimed only when the test results are non-irritating. This requirement is to avoid irritation and damage to the cornea and conjunctiva of children.
In addition, the skin irritation/corrosivity test result should be non-irritating, the skin allergenicity test conclusion should be non-sensitizing, and the skin phototoxicity test result should be non-phototoxic. These requirements are to ensure that children’s cosmetics do not cause any adverse reactions such as skin irritation, sensitization, or phototoxicity reactions.
In particular, sunscreen children’s cosmetics should be carried out by the requirements of the Technical Code for Cosmetic Safety for human skin closed patch test. The number of Grade 1 skin adverse reactions among 30 subjects should be less than or equal to 1 case, and Grade 2 and Grade 2 or more skin adverse reactions shall not occur. This requirement is to ensure the safety and efficacy of sunscreen cosmetics for children and to avoid problems such as adverse skin reactions.
7. Safety assessment
The safety assessment of children’s cosmetics must strictly follow the relevant principles and requirements of the Technical Guidelines for the Safety Assessment of Cosmetics. In this process, exposure assessment should be the leading direction, while combining the physiological characteristics of children and the product’s method of use, the use of parts, the amount of use, residue, and other specific exposure levels for a comprehensive safety assessment. It is worth noting that the Guiding Principles clearly emphasize that since the ratio of children’s body surface area to body weight is usually greater than that of adults, the systematic exposure of children is often higher than that of adults in the process of daily use of cosmetics. Therefore, the actual safe use concentration of the same raw materials in children’s cosmetics should, in principle, be lower than that in adult cosmetics.
When conducting exposure assessments for cosmetic products, we give priority to citing exposure data for children’s cosmetic products from the assessment documents of domestic and foreign cosmetic research organizations or the literature of publicly published exposure studies. These data provide us with valuable reference information, allowing us to conduct safety assessments more accurately.
The formulation design of children’s cosmetics should follow the principles of prioritizing safety, the necessity of efficacy, and minimal formulation. When considering the selection and utilization of raw materials, we need to conduct a comprehensive evaluation from various aspects, such as safety, stability, function, and compounding of raw materials. Especially for key ingredients such as flavors and fragrances, colorants, preservatives, and surfactants, their scientificity and necessity should be given high priority. Throughout the process, we always emphasize and pay attention to the safety of children’s cosmetics to ensure that every step of the operation meets the requirements of relevant regulations and guidelines, to provide safe, effective, and reliable cosmetic products for the majority of children’s consumers.